Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000438358
Ethics application status
Approved
Date submitted
23/03/2017
Date registered
27/03/2017
Date last updated
4/02/2020
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cancer Care: The risk factors of venous access failure.
Scientific title
Cancer Care: The risk factors of venous access failure. A prospective observational study of peripheral and central venous catheter outcomes among adult patients within a tertiary care setting.
Secondary ID [1] 290951 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CARETaKER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral and central venous catheter failure 301686 0
Cancer 302617 0
Condition category
Condition code
Public Health 301394 301394 0 0
Health service research
Cancer 302140 302140 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with a peripheral intravenous catheter admitted to cancer care services unit, within the preceding 48 hour period will be identified prospectively. Consenting patients will have demographic data collected: e.g. admitting diagnosis, co-morbidities, skin and vein condition, cannula insertion details. Participants will be reviewed by a research nurse second daily and collect other risk factors including (but not limited to): antibiotic use, type and dosage, flushing regime, continuous or intermittent intravenous fluid administration, dressing and other securement types, presence of extension tubing or 3-way taps, catheter type and size. Details will be collected for all peripheral venous catheters the patient receives , as well as any subsequent central venous catheters during their hospital admission. Participants will be monitored until discharge from hospital.
Intervention code [1] 296896 0
Not applicable
Comparator / control treatment
Not applicable - Observational study only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301492 0
Update All cause peripheral venous catheter (PVC) failure: A composite of infection (suspected or laboratory confirmed local or bloodstream infection), occlusion, infiltration, leakage, dislodgement (complete or partial), or phlebitis. This composite measure incorporates the multifocal path to the same endpoint; PVC failure.
Timepoint [1] 301492 0
At the time of PVC removal.
Secondary outcome [1] 332840 0
PVC dwell time: calculated time (in hours) from device insertion until removal
Timepoint [1] 332840 0
At the time of PVC removal.
Secondary outcome [2] 333045 0
Insertion of a Central Venous Access Device (CVAD)
Timepoint [2] 333045 0
Second-daily assessment until time of patient discharge or death.
Secondary outcome [3] 333046 0
CVAD Failure:
A composite measure of any reason for unplanned CVAD removal, including infection, occlusion, dislodgement and venous thrombosis.
Timepoint [3] 333046 0
At the time of CVAD removal.
Secondary outcome [4] 333047 0
Adverse events: any adverse event relating to the lack of appropriate, safe and effective intravenous access (including missed treatment and/or infiltration of vesicant agents).
Timepoint [4] 333047 0
Second-daily assessment until time of patient discharge or death.
Secondary outcome [5] 333048 0
Length of hospital stay
Timepoint [5] 333048 0
Date of admission will be collected upon enrolment, and date of discharge or death will be collected upon the patient's removal from the study.

Eligibility
Key inclusion criteria
(1) Cancer Care Services inpatient
(2) Patient able to provide informed consent
(3) PVC inserted within 48hours of admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients who are on a care of the dying pathway
(2) Non-English speaking background (NESB) without an available interpreter
(3) Previous enrolment in the study

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Continuous data will be presented as means (and standard deviations), medians (and inter-quartile ranges); and categorical, nominal data will be presented as rates and percentages. For the primary outcomes, patients who experience peripheral vascular catheter failure will be compared against those who did not. Preliminary analysis will be performed to identify associations between risk factors and outcomes using independent sample t-tests or Chi-square tests, results will be presented as crude odds ratios (OR) and 95% confidence intervals (CI) or mean differences (MD) with their 95% CI. Predictors significant at the 0.1 level will inform multivariable modelling. As part of the analysis, potentially confounding factors and multicollinearity will be assessed. Survival analysis will be used to evaluate time-to-event data (e.g. time to catheter failure).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2017
Actual
20/10/2017
Date of last participant enrolment
Anticipated
6/07/2018
Actual
13/02/2019
Date of last data collection
Anticipated
20/07/2018
Actual
2/03/2019
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7689 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 15607 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 295937 0
Charities/Societies/Foundations
Name [1] 295937 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 295937 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Rd
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 294827 0
Hospital
Name [1] 294827 0
Royal Brisbane and Women's Hospital
Address [1] 294827 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Rd
Herston, QLD 4029
Country [1] 294827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297218 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 297218 0
Ethics committee country [1] 297218 0
Australia
Date submitted for ethics approval [1] 297218 0
10/01/2017
Approval date [1] 297218 0
02/03/2017
Ethics approval number [1] 297218 0
HREC/17/QRBW/7
Ethics committee name [2] 297219 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 297219 0
Ethics committee country [2] 297219 0
Australia
Date submitted for ethics approval [2] 297219 0
02/03/2017
Approval date [2] 297219 0
14/03/2017
Ethics approval number [2] 297219 0
2017/154

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71822 0
Ms Emily Larsen
Address 71822 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston
QLD 4006
Country 71822 0
Australia
Phone 71822 0
+61 7 3646 8725
Fax 71822 0
Email 71822 0
[email protected]
Contact person for public queries
Name 71823 0
Emily Larsen
Address 71823 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston
QLD 4006
Country 71823 0
Australia
Phone 71823 0
+61 7 3646 8725
Fax 71823 0
Email 71823 0
[email protected]
Contact person for scientific queries
Name 71824 0
Emily Larsen
Address 71824 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston
QLD 4006
Country 71824 0
Australia
Phone 71824 0
+61 7 3646 8725
Fax 71824 0
Email 71824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per Human Research Ethics Committee approval conditions, no individual participant data will be publically available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1668Ethical approval    372191-(Uploaded-19-03-2019-16-56-44)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInherent and modifiable risk factors for peripheral venous catheter failure during cancer treatment: a prospective cohort study.2021https://dx.doi.org/10.1007/s00520-020-05643-2
N.B. These documents automatically identified may not have been verified by the study sponsor.